Effect of Increased Fruit and Vegetable Intake on Chronic Obstructive Pulmonary Disease (COPD) (DISCO)

This study has been completed.
Sponsor:
Information provided by:
Queen's University, Belfast
ClinicalTrials.gov Identifier:
NCT00435708
First received: February 14, 2007
Last updated: November 6, 2009
Last verified: November 2009
  Purpose

Chronic obstructive pulmonary disease (COPD) is the UK's fastest growing fatal disease and is estimated to cost the health service close to £1 billion every year. Around 80,000 people in Northern Ireland suffer from COPD. COPD is clinically defined as a slowly progressive condition characterised by airflow limitation, which is largely irreversible. Chronic inflammation and oxidative stress are key components of the underlying pathological process resulting in airflow limitation. Dietary factors and nutrients that have antioxidant or anti-inflammatory properties are therefore of interest with respect to the aetiology of COPD. The antioxidant vitamins C, E and beta-carotene are all present in the lung milieu. Such antioxidants represent the lung's first line of defence against oxygen free radicals. Observational studies indicate that a low dietary intake of antioxidant nutrients, or foods rich in antioxidants (e.g. fruit and vegetables), is associated with decreased lung function and increased risk of COPD. To date, there have been no food-based dietary interventions investigating the effect of increased fruit and vegetable intake on COPD. The investigators propose to recruit people with mild to moderate COPD and low fruit and vegetable intakes (<=2 portions daily) and randomise them to one of two study arms for 12 weeks - either to increase fruit and vegetable consumption to at least 5 portions a day, or to follow their normal diet. Airway and systemic oxidative stress and inflammation will be assessed at baseline and post-intervention in order to determine if fruit and vegetables have the potential to alleviate the oxidative stress and airway inflammation associated with COPD.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Behavioral: 5 portions fruit and vegetables/day
Behavioral: <= 2 portions fruit and vegetables/day
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Increased Fruit and Vegetable Intake on Airway Inflammation and Oxidative Stress in Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by Queen's University, Belfast:

Primary Outcome Measures:
  • Self-reported intake of fruit and vegetables (number of portions per day); Markers of airway inflammation in induced sputum [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biochemical markers of nutritional status; systemic and airway oxidative stress; systemic inflammation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 81
Study Start Date: February 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
<= 2 portions fruit and vegetables/day'
Behavioral: <= 2 portions fruit and vegetables/day
Participants continue to consume usual diet containing <= 2 portions fruit and veg per day
Experimental: 2
5 portions fruit and vegetables/day
Behavioral: 5 portions fruit and vegetables/day
Participants consume > = 5 portions fruit and veg per day

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • moderate to severe COPD (according to GOLD classification)
  • oxygen saturation >= 92 KPa
  • symptomatically stable
  • habitually low fruit and vegetable intakes (<=2 portions daily)
  • exercise limited by shortness of breath (rather than e.g. angina, arthritis)

Exclusion Criteria:

  • diabetes
  • taking antioxidant supplements or drugs
  • oxygen saturation <8KPa
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00435708

Locations
United Kingdom
Queen's University Belfast
Belfast, Co.Antrim, United Kingdom, BT12 6BJ
Sponsors and Collaborators
Queen's University, Belfast
Investigators
Principal Investigator: Ian Young, MD Queen's University, Belfast
  More Information

No publications provided by Queen's University, Belfast

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr M McKinley, Lecturer
ClinicalTrials.gov Identifier: NCT00435708     History of Changes
Other Study ID Numbers: Ref 200651
Study First Received: February 14, 2007
Last Updated: November 6, 2009
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Queen's University, Belfast:
COPD
Fruit
Vegetables
Oxidative stress
Inflammation

Additional relevant MeSH terms:
Inflammation
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 01, 2014